Kornimate/medical-research-clean huggingface dataset:
rehabilitation in sod1 als treated with tofersen

Conditions: Amyotrophic Lateral Sclerosis; Lou Gehrig Disease; Familial Amyotrophic Lateral Sclerosis; Motor Neuron Disease; Motor Neuron Disease, Familial

Summary: the primary objective of this study is to document and describe the effects of a personalized rehabilitation program for patients with sod1 als participating in the tofersen expanded access program. participants currently receiving tofersen treatment will be referred to outpatient physical and/or occupational therapy. participants will have an initial assessment performed and an individualized rehabilitation program will be prescribed. each participant is encouraged to follow the prescribed recommendations that will include scheduled outpatient therapy sessions, functional assessments, and/or a home-based rehabilitation program. functional assessments will be done at a minimum of every three months.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of als with an sod1 mutation * current enrollment in the tofersen expanded access program * age greater than 18 years * medically able to participate in outpatient physical therapy and/or home-based rehabilitation, as determined by the treating health care provider exclusion criteria: * any comorbidities or conditions that, in the opinion of the treating healthcare provider, would unacceptably increase the risk of participation in outpatient physical therapy and/or home-based rehabilitation
effect of early prosthetic fitting in patients with below-knee amputation

Conditions: Amputation Stump

Summary: a randomized control trial of 50 patients to identify the effect of early prosthetic fitting and physical rehabilitation. previous studies show a significant impact of early induction of prosthetic rehabilitation of amputation. delayed rehabilitation may cause severe physical complications like joint contracture, and muscle strength loss.

along with physical complications delays in rehabilitation may also significantly affect psychological, economic, and quality of daily life. pakistan is a low-income developed country and the major cause of amputation here is traumatic amputation, which affects mostly younger age people. after missing a precious body part if the amputee comes along with such kind of physical and psychological complications, his/her whole daily life will be affected. there is a keen need for the implementation of global rules for physical rehabilitation of amputees and disabled including the duration of induction of prosthetics as well as overall physical rehabilitation after surgical and traumatic removal of limbs.

Eligibility criteria:
inclusion criteria: * male and female below-knee amputees due to trauma and diabetes were included exclusion criteria: * patients with comorbidities and old users of prostheses were excluded
the kin-fast trial (kin001 for accelerated symptoms termination) in non hospitalized patients infected with sars-cov-2

Conditions: COVID-19

Summary: clinical trial on safety and efficacy of kin001 in non-hospitalized patients with covid-19.

this is a prospective, double-blind, randomized and placebo-controlled phase ii trial to evaluate the safety and efficacy of kin001 in non-hospitalized patients suffering from covid-19. randomization to one of two treatment arms (kin001 versus placebo) is at a ratio of 1:1. patients will receive treatment for 14 days and followed for another 14 days. the primary outcome is patient reported covid-19 symptoms, using the fda questionnaire developed for assessing covid-19-related symptoms in outpatients. the trial will be conducted in switzerland and germany.

Eligibility criteria:
inclusion criteria: 1. diagnosis of symptomatic covid-19 of less than 5 days' duration, with at least 1 point in at least 4 items of the symptom evaluation table, and at least 2 points in at least 2 items, or a minimum total score of 6 points 2. diagnosis of covid-19 confirmed in the last 48 hours by a positive test for sars-cov-2 rna by rt pcr or a rapid validated antigen test (excluding self-test), in a specimen from the upper respiratory tract, the saliva (antigen test), the lower respiratory tract or an expectorated sputum 3. no indication that the patient will be hospitalized in the next 48 hours for covid-19 related reasons 4. adult male or female patients aged ≥ 18 years 5. females must have a negative pregnancy test or must be post-menopausal 6. able to understand and willing to sign an irb/iec approved written informed consent document. 7. able to understand and be available for daily phone calls to evaluate symptoms. exclusion criteria: 1. patients with an indication for hospitalization (e.g. spo2 \<92%) 2. patients participating in another clinical trial with a new investigational drug or investigational non-drug treatment 3. known allergy or intolerance to pamapimod or any other ingredient of the imp or another p38 inhibitor 4. known allergy or intolerance of clinical relevance to pioglitazone or any other ingredient of the imp. 5. patients where oral administration of pioglitazone is contraindicated (i.e. cardiac failure or history of cardiac failure (nyha stages i to iv), with hepatic impairment, diabetic ketoacidosis, current bladder cancer or a history of bladder cancer, uninvestigated macroscopic haematuria 6. any use of cyp450 2c8 inducers (e.g. rifampicin) 7. known or suspected active viral (including hiv, hepatitis b, hepatitis c), bacterial, mycobacterial or fungal infection other than covid-19. virologic testing not required unless infection is suspected. 8. pregnant or breastfeeding women 9. any uncontrolled concurrent illness that would put the patient at a greater risk or limit compliance with the study requirements as determined at the discretion of the investigator 10. liver enzyme elevation more than 3x above normal in the last 4 weeks or at inclusion 11. patients who are detained or committed to an institution by a law court or by legal authorities (subject is vulnerable, such as deprived of freedom)
allergy and ashthma in children who were fed supplemented infant formula

Conditions: Allergy and Asthma

Summary: allergy and asthma study of children (3 - 7 years of age) who participated in randomized trials of supplemented infant formula during infancy conducted by the retina foundation of the southwest .


Eligibility criteria:
inclusion criteria: * children who participated in randomized trials of supplemented infant formula conducted by the retina foundation of the southwest during infancy exclusion criteria: -
central apnea in patients receiving ticagrelor

Conditions: Acute Coronary Syndrome

Summary: all patients with a left ventricular ejection fraction superior or equal to 50% less than 2 years after an acute coronary event and receiving ticagrelor will undergo a sleep polygraphy

all patients with a left ventricular ejection fraction superior or equal to 50% less than 2 years after an acute coronary event and receiving ticagrelor will undergo a sleep polygraphy the main objective of the study will be to look for central sleep apnea

Eligibility criteria:
inclusion criteria: * patient receiving ticagrelor 10 days to 2 years after an acute coronary syndrome exclusion criteria: * left ventricular ejection fraction \< 50% * patients refusal
safety and efficacy of s-707106 in subjects with type 2 diabetes mellitus and inadequate glycemic control with metformin therapy

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the safety and efficacy of s-707106 co-administered with metformin in subjects with type 2 diabetes mellitus.

based on the unmet clinical need for more safe and effective type 2 diabetes mellitus therapies, together with the nonclinical efficacy and safety profile of s-707106, shionogi usa, inc. is initiating studies to further assess the efficacy, clinical pharmacology and safety profile of s-707106 in preparation for full clinical development as a novel treatment for type 2 diabetes mellitus. it is anticipated that s-707106 will provide clinicians and patients with a new therapeutic option to treat type 2 diabetes mellitus with potential advantages over existing therapy.

Eligibility criteria:
main inclusion criteria: * subjects with type 2 diabetes mellitus receiving a stable dose of metformin for the past 3 months (with no other medication for glycemic control) and who are clinically stable as determined by medical history * body mass index (bmi) ≥25.0 and \<45.0 (kg/m2) using http://www.bmicalculator.org/ as the bmi calculator * no clinically significant abnormal laboratory tests as determined by the investigator except hemoglobin a1c level ≥7.5% and ≤11.0% and c peptide level \>1.0 ng/ml main exclusion criteria: * type 1 diabetes mellitus or gestational diabetes mellitus within last 6 months * use of any medication for glycemic control other than metformin during the past 3 months or thiazolidinediones within the past year * congestive heart failure as defined by new york heart association class iii or iv * fasting glucose \>270 mg/dl * creatinine clearance is \<60 ml/minute * history of myocardial infarction within the past 3 months, history of clinically significant cardiac arrhythmia, clinically significant hypotension or hypertension, or clinically significant abnormal electrocardiogram as determined by the investigator

Keywords: type 2 diabetes mellitus metformin
predictors of postoperative complications in surgery with pneumoperitoneum in the trendelenburg position

Conditions: Trendelenburg Position; Pneumoperitoneum

Summary: evaluate early postoperative complications after surgery in trendelenburg position with increased intraabdominal pressure (surgery with pneumoperitoneum). evaluate the relationship between hemodynamic and metabolic changes on perioperative outcome.


Eligibility criteria:
inclusion criteria: * asa class i-iv. * planned for laparoscopic surgery in the trendelenburg position that is expected to last more than 2 hours. * planned arterial catheter insertion. exclusion criteria: * pregnancy. * planned open abdominal surgery. * renal replacement therapy.
maintenance therapy with autologous cytokine-induced killer cells for nonsquamous non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: maintenance therapy has been considered as an important component to prolong survival in patients with advanced nonsquamous non-small cell lung cancer (nsclc). previous studies have confirmed that pemetrexed is one of the effective drugs in improving progression-free survival for stage iiib-iv nonsquamous non-small cell lung cancer. with the periodic deliveries of pemetrexed, however,the functioning status and immune system may get worse, which subsequently has an negative impact on patient's quality-of-life. immunotherapy with autologous cytokine-induced killer (cik) cells can activate the antitumor defense mechanism through stimulating immune response and altering the interaction between tumor and its host. this effect may result in improved tumor control and survival, as well as a better quality of life. to test the hypothesis, a randomised controlled study was conducted to compare cik cells with pemetrexed as maintenance therapy for stage iiib-iv nonsquamous non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: * histologically or cytologically proven nonsquamous non-small cell lung cancer * stage iiib-iv, according to ajcc 2010 staging system * disease measurable * patients are currently receiving two-drug chemotherapy regimen containing a platinum-based drug as first-line therapy * no chemotherapy or radiotherapy prior to first-line therapy * age between 18-75 * performance status \<2 * no congestive heart failure, severe arrhythmia,and coronal atherosclerosis heart disease * no uncontrolled metabolic disease, infection, and neurological disorders * no other malignancies * signed study-specific consent form prior to study entry exclusion criteria: * patients are currently receiving radiotherapy or any chemotherapy regimen other than two-drug containing a platinum-based drug as first-line therapy * pregnant or lactating women * patient having hepatitis b virus infection, active tuberculosis, or other infectious diseases

Keywords: nonsquamous non-small cell lung cancer maintenance therapy immunotherapy autologous cytokine-induced killer cell pemetrexed
gwas research of lung cancer in tianjin

Conditions: Non-small Cell Lung Cancer; Primary Carcinoma

Summary: to study the association of genetic polymorphisms with lung cancer risk in tianjin population.

eligibility criteria: * nonsmoker * female * age between 35 and 80 * no other types of tumors history * frequency-matched cases and controls on gender and age outcome measures: * or(odds ratio) * rr(risk ratio) * ci(confidence interval) * sas software

Eligibility criteria:
inclusion criteria: * non-small cell lung cancer * age from 35 to 80 years old * female * non-smokers * frequency-matched on age and gender exclusion criteria: * previous medical history of cancer * previous radiotherapy * previous chemotherapy

Keywords: genome-wide association studies(gwas) single nucleotide polymorphism(snp) lung cancer
use of virtual reality for overdose management educational trainings

Conditions: Drug Overdose; Virtual Reality

Summary: this cluster-randomized trial will compare changes in attitudes and knowledge on administering naloxone based on exposure to either a virtual reality educational training or the current standard educational trainings (e.g. on-line videos, printed information handouts) offered at local libraries. individuals attending local library's naloxone training days will voluntarily complete an anonymous validated survey pre and post attending either the virtual reality or standard educational training.

this study will utilize a cluster-randomized trial design. entire libraries will be randomized to either offer community members the virtual reality training or the standard educational offerings (e.g. handouts, online videos). volunteers will be asked to complete the brief, anonymous, and validated opioid overdose knowledge scale prior to receiving an education intervention (pretest) and then again immediately after (posttest). neither participants nor investigators will be blinded. library patrons who do not participate in the study will be offered current standard training materials. regardless of the library's randomization, to either virtual reality or standard training, all patrons completing pre and post test surveys will have the opportunity to view the virtual reality training or other public health department materials.

Eligibility criteria:
inclusion criteria: * able to complete paper surveys independently * provide verbal consent exclusion criteria: * unable to complete immediate post-training assessment * individuals under 18 years of age * individuals who cannot communicate in english and provide consent
effects of pre-event massage on muscle activity

Conditions: Neuromuscular Diseases

Summary: the study observes the effect of a pre-event massage on the gastrocnemius and hamstring muscles on muscle activity.


Eligibility criteria:
inclusion criteria: - exclusion criteria: * muscle injury in the last two months * suffer a musculoskeletal disorder that doesn't allow the subject to do the study protocol

Keywords: pre-competition massage pre-event massage gastrocnemius superficial electromyography hamstrings
a mobile health and wellness coaching intervention for weight loss

Conditions: Overweight and Obesity; Health Behavior

Summary: the objective of this study was to assess the effectiveness of a 6-month text-based mobile health and wellness (mhwc) intervention, as compared to usual care (uc), for weight loss in adults. participants were randomly assigned to one of the two groups (mhwc or uc). at the beginning of the study, both groups were given a fitbit wearable device, and a weight scale. all participants also received a counseling session from a dietician focused on diet, physical activity, and sleep, and were set up on the nudge app, a commercially-available mhwc platform. participants in the mhwc group received text-based coaching messages via nudge and did not return to the clinic for the duration of the 6-month intervention. those in the uc group met once a month with a pharmacist or dietician for 6 months. in both groups, the focus was on facilitating health behavior change related to diet, physical activity, and sleep to promote weight loss. we hypothesized that weight loss at 6 months would be greater in the mhwc group vs. the uc group.


Eligibility criteria:
inclusion criteria: * bmi ≥27 kg/m\^2 * waist circumference ≥35 inches (women) or ≥40 inches (men) * own an android smartphone or iphone capable of running the nudge and fitbit applications. * indicate sending at least one text-based (e.g., sms, facebook, twitter) message via their smartphone on most days exclusion criteria: * pregnant * pacemaker or other electronic implant * weight ≥400 pounds * weight loss ≥5% of bodyweight in previous 6 months * high cardiovascular risk, as determined by physical activity readiness questionnaire (par-q) and physician review, as needed.

Keywords: health and wellness coaching
tetracaine combined spinal epidural (cse) versus bupivacaine cse

Conditions: Labor Pain

Summary: the investigators hypothesis is that spinal tetracaine with fentanyl and epinephrine used for cse labor analgesia volume will last a significantly longer period of time that that of spinal bupivacaine with fentanyl. after informed consent is obtained for the study, subjects meeting criteria when analgesia is requested will be randomized to receive a combined spinal-epidural containing either tetracaine 2 mg with fentanyl and epinephrine or bupivacaine 2 mg with fentanyl and epinephrine.


Eligibility criteria:
inclusion criteria: * early labor (\>=2cm but =\<6cm cervical dilation) * at least 12 years of age * have an assigned asa physical status 1 or 2 * singleton pregnancy exclusion criteria: * contraindications to neuraxial anesthesia * with allergies to drugs used in the study * have an assigned asa status 3 or 4 * advanced labor (\> 6cm cervical dilation) * less than 12 years of age * patients with the potential for distorted epidural anatomy, such as harrington rods or prior back surgery, will also be excluded.

Keywords: labor pain combined spinal epidural labor analgesia cse analgesia labor analgesia
a study of tocilizumab (roactemra/actemra) versus adalimumab in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this randomized, blinded, parallel arm study evaluated the efficacy and safety of tocilizumab (roactemra/actemra) versus adalimumab as monotherapy in patients with rheumatoid arthritis who are intolerant of methotrexate or where continued treatment with methotrexate was considered inappropriate. patients were randomized to receive either tocilizumab 8 mg/kg intravenously (iv) every 4 weeks plus placebo subcutaneously (sc) every 2 weeks, or adalimumab 40 mg sc every 2 weeks plus placebo iv every 4 weeks. treatment was anticipated to last 24 weeks. with regard to the blind, the study nurse was unblinded due to the nature of the treatment administration, but the investigator and the patient remained blinded.


Eligibility criteria:
inclusion criteria: * adult patients, ≥ 18 years of age. * rheumatoid arthritis of \> 6 months duration. * intolerant of methotrexate or continued treatment with methotrexate is considered inappropriate. * all disease-modifying anti-rheumatic drugs (dmard) are to be withdrawn prior to receiving study drug. * weight ≤ 150 kg. exclusion criteria: * major surgery (including joint surgery) within 12 weeks prior to baseline or planned major surgery within 6 months after baseline. * history of or current inflammatory joint disease other than rheumatoid arthritis (ra). * treatment with a biologic agent at any time prior to baseline. * intra-articular or parenteral corticosteroids ≤ 4 weeks prior to baseline. * active current infection or history of recurrent bacterial, viral, fungal or mycobacterial infection.
sleep for inpatients: empowering staff to act

Conditions: Sleep Disorders; Sleep

Summary: getting better sleep in the hospital is especially important due to a variety of adverse health effects that can potentially worsen patient recovery. to address these concerns and improve sleep in us hospitals, we aim to develop the siesta (sleep for inpatients: empowering staff to act) program as an educational intervention designed to prepare hospital staff to assist patients in obtaining better sleep in hospitals and recognize the importance of screening for sleep disorders. the major educational goals of this proposal is to develop and pilot test an online educational program (siesta) which aims to train and motivate medical professionals to provide better sleep for hospitalized patients. we will utilize data from an ongoing sleep study, performed by the research team at the university of chicago that looks at how adult patients are able to sleep while they are in the hospital, as a means of education for the participating medical staff.


Eligibility criteria:
inclusion criteria: * to be eligible to participate in this study, the subjects must be university of chicago hospital employees over the age of 18 years old. exclusion criteria: * we will exclude any hospital staff under the age of 18 years old from this study as well as hospital patients and non-hospital staff.

Keywords: staff empowerment sleep apnea educational intervention
renin and renal biomarker response to angiotensin ii

Conditions: Septic Shock; Acute Kidney Injury

Summary: septic shock continues to exert a large economic burden around the world. several developments have occurred that lead to the current study. first, angiotensin ii is the newest fda approved vasopressor agent indicated for use in vasodilatory shock. several subgroups from the approval trial have indicated that angiotensin ii may confer a survival benefit in certain conditions, including those patients requiring continuous renal replacement therapy, those with altered angiotensin i: angiotensin ii ratios, and most recently, those with elevated renin levels (which may serve as a surrogate for dysfunctional angiotensin 1: angiotensin ii ratios). this open-label, sequential period pilot study will evaluate angiotensin ii and biomarker response (renin) in the treatment of septic shock.


Eligibility criteria:
inclusion criteria: * medical icu admission * septic shock * norepinephrine requirement = 0.15 mcg/kg/min for = 30 minutes (if cirrhosis, norepinephrine requirement = 0.1 mcg/kg/min for = 30 minutes) * kidney disease improving global outcomes stage 1 or greater acute kidney injury exclusion criteria: * prisoner * pregnancy * acute occlusive coronary syndrome requiring intervention or acute myocardial infarction of any degree * purely cardiogenic shock (no distributive component) * mesenteric ischemia * acute ischemic stroke * hemorrhagic shock * active treatment of hepatorenal syndrome targeting a mean arterial pressure = 65 mm hg * planned withdrawal of care within next 24 hours or no escalation of care * patient enrolled in an interventional study * high likelihood of medical futility in using this drug: * 3 or more vasopressors required to sustain map * sustained norepinephrine equivalents \> 0.5 mcg/kg/min * covid-19 positive, or high suspicion of covid-19

Keywords: renin angiotensin ii vasopressor sepsis
rethink for mental health of the youths in romania

Conditions: Bullying of Child; Bullying Victimisation; Bullying

Summary: in order to test the effect of the intervention, a multi-center randomized control trial (rct) will be conducted to test the efficacy of the rethink interventions on improving bullying (both victimization and aggression) and mental health compared with a care as usual group. a minimum of 1000 students from the participating institutions (schools will be able to join based on a recruitment call), will be recruited and randomly assigned to either the experimental or control group.


Eligibility criteria:
inclusion criteria: * internet and pc access to complete the scales and game exclusion criteria: * no internet or pc access